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ANZGOG 0902/GOG-0274/RTOG 1174
Informed Consent
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GYNECOLOGIC ONCOLOGY GROUP
RADIATION THERAPY ONCOLOGY GROUP
SUGGESTED PATIENT INFORMATION/INFORMED CONSENT
TITLE OF RESEARCH PROJECT: A PHASE III TRIAL OF ADJUVANT CHEMOTHERAPY
AS PRIMARY TREATMENT FOR LOCALLY ADVANCED CERVICAL CANCER COMPARED
TO CHEMORADIATION ALONE: THE OUTBACK TRIAL (ANZGOG 0902/GOG-0274/RTOG
1174)
PRINCIPAL INVESTIGATOR:
GENERAL
This is a clinical trial, a type of research study. Your study doctor will explain the clinical trial to you.
Clinical trials include only people who choose to take part. Please take your time to make your
decision about taking part. You have also been told that you have the option not to participate. You
may discuss your decision with your friends and family. You can also discuss it with your health care
team. If you have any questions, you can ask your study doctor for more explanation.
This study is being carried out under the sponsorship of the Gynecologic Oncology Group (GOG), an
organization dedicated to clinical research in the field of gynecologic cancer and the Radiation
Therapy Oncology Group (RTOG). Both the GOG and RTOG are funded by the Federal Government
through the National Cancer Institute (NCI).
The clinical components of the trial including participation from member institutions from the GOG
and RTOG will be managed and coordinated by the Australia New Zealand Gynaecological Oncology
Group (ANZGOG). Specimen banking and tissue research from GOG member institutions will be
managed and coordinated by the GOG, and specifically the GOG Tissue Bank. Specimen banking and
tissue research from RTOG member institutions will be managed and coordinated by the RTOG
Biospecimen Resource.
You are being asked to take part in this study because you have been diagnosed with cervical cancer
which is locally advanced and not suitable for surgery. The alternative to treatment on this trial is to
receive standard cisplatin chemotherapy given at the same time as radiation.
WHY IS THIS STUDY BEING DONE?
The purpose of this study is to compare standard treatment, radiation therapy combined with the
chemotherapy drug cisplatin (chemo-radiation), to standard chemo-radiation therapy plus additional
experimental chemotherapy with FDA approved agents carboplatin and paclitaxel to see if it reduces
the risk of tumor recurrence and improves overall survival.
Studies among patients with other cancer types have shown that the addition of more
chemotherapy after chemo-radiation reduces the risk of tumor recurrence at other places in the
body. This has not yet been clearly established for cervical cancer patients. Giving additional
chemotherapy after initial standard treatment is known as ‘adjuvant chemotherapy’.
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The objectives of this trial are to find out whether adjuvant chemotherapy (using two other
drugs) after chemo-radiation will increase the chances of survival and reduce the risk of tumor
recurrence in the pelvis and other places. The risk and severity of side effects and quality of life
during and after treatment will also be evaluated and compared. This trial will help the
researchers understand the safety and effectiveness of this new treatment regimen for cervical
cancer.
In this trial one group will receive standard chemo-radiation alone, whereas the other group will
receive standard chemo-radiation and then additional chemotherapy.
Another purpose of this study is to test samples of your tumor tissue (if available from a previous
surgery or biopsy) and your blood to find out if any of these tests can be used in the future to determine
which patients may respond to treatment, have a good prognosis, or have side effects.
HOW MANY PEOPLE WILL TAKE PART IN THE STUDY?
A total of 780 women will participate in this study internationally. Both the GOG and RTOG
anticipates enrolling approximately half of these patients.
WHAT WILL HAPPEN IF I TAKE PART IN THIS RESEARCH STUDY?
Before you begin the study
You will need to have the following exams, tests or procedures to find out if you can be in the study.
These exams, tests or procedures are part of regular cancer care and may be done even if you do not
join the study. If you have had some of them recently, they may not need to be repeated. This will be
up to your study doctor.
 History and physical examination which will include a pelvic examination
 Height and weight measurements
 Blood tests to measure blood counts, blood mineral levels, and check liver and kidney
function
 A pregnancy test if you are capable of becoming pregnant
 CT scan of the chest, abdomen and pelvis
 An MRI of the pelvis and/or PET scan of your entire body are optional studies which
will be offered to you as part of your pre-treatment evaluation
 Review of medications and supplements you are currently taking
You will undergo the following procedures that are not part of regular cancer care and are being done
only because you are in this study:
 Complete five quality of life questionnaires during regularly scheduled pretreatment office visits. It will take approximately 30 minutes to complete the
questionnaires.
 You will be asked to provide samples of your tumor (if available from a previous
surgery or biopsy) and 8 teaspoons of your blood for testing that is not part of regular
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cancer care and is being done only because you are in this study. You can still
participate in this study even if you do not give permission for your tumor tissue
and your blood to be submitted and used for this optional research. For more
information on this optional research, please see the last three sections of this document.
One section provides general information about the collection and use of specimens for
research. Another section describes specific information about the use of specimens for
this research study. The last section focuses on issues regarding future research.
During the study
If the exams, tests and procedures show that you can be in the study, and you choose to take part, then
you will need the following tests and procedures. They are part of regular cancer care.


History and physical examination which may include a pelvic examination
Blood tests to measure blood counts, blood mineral levels and check liver and kidney
function.
You will undergo the following procedures that are not part of regular cancer care and are being done
only because you are in this study.

Complete five quality of life questionnaires during regularly scheduled pretreatment office visits. It will take approximately 30 minutes to complete the
questionnaires.

You will be asked to provide samples of your tumor if you require another biopsy for
clinical reasons (such as confirmation of diagnosis). If you do not require another
biopsy for clinical reasons then you DO NOT need a repeat biopsy.
You will be "randomized" into one of the study groups described below. Randomization means that
you are put into a group by chance. A computer program will place you in one of the study groups.
Neither you nor your doctor can choose the group you will be in. You will have an equal chance of
being placed in any group.
If you are in Arm A (Control Arm) you will be given the current standard treatment for this
type of cancer and side effects and quality of life information will be collected and compared
with the intervention arm. This group will receive chemo-radiation (standard radiation therapy
plus cisplatin chemotherapy) only. This means you will receive standard external radiation
therapy daily for five weeks. Following external radiation, intracavitary radiation (radiation
delivered directly to the cervix through the vagina) will be administered. Depending on the
type of intracavitary treatment administered, you may receive 1-5 intracavitary placements.
The administration of cisplatin will take approximately 30-60 minutes each time. The radiation
therapy will be given over eight weeks. The cisplatin chemotherapy will be given in five
treatments, weekly during the course of the radiation therapy.
If you are in Arm B (Intervention Arm) you will be given treatment that involves more than
the standard treatment for this type of cancer. Side effects and quality of life information will
be compared with the standard arm. This group will receive chemo-radiation (standard
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Informed Consent
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radiation therapy plus cisplatin chemotherapy), followed by carboplatin and paclitaxel
chemotherapy. This means you will receive standard external radiation therapy daily for five
weeks. Following external radiation, intracavitary radiation (radiation delivered directly to the
cervix through the vagina) will be administered.
Depending on the type of intracavitary
treatment administered, you may receive 1-5 intracavitary placements. The administration of
cisplatin will take approximately 30-60 minutes each time. The radiation therapy will be given
over eight weeks. The cisplatin chemotherapy will be given in five treatments, weekly during
the course of the radiation therapy. Within 4 weeks of finishing your radiation treatment, you
will start to receive additional chemotherapy called carboplatin and paclitaxel. These two
drugs will be given on one day, repeated every 3 weeks for 4 total cycles. Chemotherapy with
carboplatin and paclitaxel takes about 6 hours to infuse each time.
QUALITY OF LIFE
We want to know your view of how your life has been affected by cancer and its treatment. “Quality
of life” looks at how you are feeling physically and emotionally during your cancer treatment. It also
looks at how you are able to carry out your day-to-day activities.
This information will help doctors better understand how patients feel during treatments and what
effects the medicines are having. In the future, this information may help patients and doctors as they
decide which medicines to use to treat cancer.
You will be asked to complete five questionnaires at the following time points: before you are
randomized, at the end of your chemo-radiation treatment, before each cycle of treatment with
carboplatin and paclitaxel for those patients in Arm B, four weeks after completion of all study
treatment, then every 3 months for two years and then every 6 months in the 3rd year. It takes about 30
minutes to fill out the questionnaires each time.
If any questions make you feel uncomfortable, you may skip those questions and not give an answer.
After your treatments are completed:
To monitor your well-being and the status of your cancer, you will undergo these tests and procedures
that are part of regular cancer care:
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History and physical examination which may include pelvic examination every three
months for two years and then every six months for three years after completion of
treatment
Blood tests to assess blood cell counts, blood mineral levels, and check liver
and kidney function if your physician feels they are necessary for monitoring
A CT scan of the chest, abdomen and pelvis six months
after randomization and then as clinically indicated by your physician
A PET scan or PET/CT scan (if available) four-six months after treatment completion
Complete five quality of life questionnaires every three months for two years and then
every six months in the 3rd year after completion of treatment.
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Study Chart
If you are in Arm A, you will receive 5 weeks of external beam radiation therapy. You will receive
cisplatin intravenously (through a vein in your arm) on Day 1 of the week and radiation on Days 1-5
followed by 2 days without treatment, for 5 weeks.
If you are in Arm B you will receive 5 weeks of external beam radiation therapy. You will receive
cisplatin intravenously (through a vein in your arm) on Day 1 of the week and radiation therapy on
Days 1-5, followed by 2 days without treatment for 5 weeks. Within 4 weeks of completion of
treatment with cisplatin and all radiation treatment, and following recovery from any side effects,
patients in Arm B will receive additional intravenous (through a vein in your arm) treatment with the
chemotherapy drugs, carboplatin and paclitaxel, every 3 weeks for four cycles. This 3 week period of
time is called a cycle.
The chart below shows what will happen to you during Cycle 1 and future treatment cycles as
explained previously. The left-hand column shows the day in the cycle and the right-hand column tells
you what to do on that day.
Arm A and Arm B
Cycle 1
Day



Within 28
days before
starting
study
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Day 1
Days 2-5
Days 6-7
(weekend)
Day 8
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What you do
Have history taken and complete physical exam which will include a pelvic exam
Get a CT scan of the chest, abdomen and pelvis to check for any sign of cancer spread to
the rest of the body
MRI of the pelvis or PET scan of the entire body may be performed if available at your
treatment center
Complete the quality of life questionnaires
Get routine blood tests and urinalysis.
A pregnancy test if you are of childbearing potential
Go to your doctor’s office and undergo planning of the radiation treatment. This may
involve examination, CT scan and X-ray. You will be there for approximately 4 hours.
Optional research blood test
Physical examination that may include a pelvic examination
Go to your doctor’s office or infusion center for treatment. Cisplatin administration will
take 60 to 90 minutes to infuse and then you will receive radiation therapy.
Get radiation therapy daily.
No treatment
Get routine blood tests (more if your doctor tells you to)
Physical examination that may include a pelvic examination
Go to your doctor’s office or infusion center for treatment. Cisplatin administration will
take 60 to 90 minutes to infuse and then you will receive radiation therapy.
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Days 9-12
Days 13-14
(weekend)
Day 15
Days 16-19
Days 20-21
(weekend)
Day 22
Days 23-26
Days 27-28
(weekend)
Day 29
Days 30-33
Day 34
4 weeks
after your
radiation
therapy is
completed

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
As with all aspects of your cancer care, call the doctor if you do not know what to do.
Get radiation therapy
No treatment



Get routine blood tests (more if your doctor tells you to)
Physical examination that may include a pelvic examination
Go to your doctor’s office or infusion center for treatment. Cisplatin administration
will take 60 to 90 minutes to infuse and then you will receive radiation therapy.
As with all aspects of your cancer care, call the doctor if you do not know what to do.
Get radiation therapy daily
No treatment






Get routine blood tests (more if your doctor tells you to).
Physical examination that may include a pelvic examination
Go to your doctor’s office or infusion center for treatment. Cisplatin administration
will take 60 to 90 minutes to infuse and then you will receive radiation therapy.
Get radiation therapy daily
No treatment





Get routine blood tests (more if your doctor tells you to).
Physical examination that may include a pelvic examination
Go to your doctor’s office or infusion center for treatment. Cisplatin administration
will take 60 to 90 minutes to infuse and then you will receive radiation therapy
Get radiation therapy daily
Treatment complete for patients in Arm A
Patients in Arm B with proceed with additional chemotherapy treatments within the
next four weeks once any side effects have resolved
Get routine blood tests
Physical examination that may include a pelvic examination
Complete the quality of life questionnaires

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
Arm B-Cycle 1 with Carboplatin and Paclitaxel
Day
Between Days
18 & 21
What you do
 Pre-chemotherapy medications by IV or mouth to prevent allergic reactions
 IV paclitaxel and carboplatin therapy. Infusion of these drugs takes approximately 6
hours
 Physical examination that may include a pelvic exam
 Routine blood tests
 Complete quality of life questionnaires
Day 22

Days 1
Return to your doctor’s office for your next exam and to begin the next cycle.
GOG-0274/RTOG 1174/ANZGOG-0902 Patient Information and Consent Form version 1.0, 01 December 2011
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Informed Consent
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Arm B-Cycles 2-4 with Carboplatin and Paclitaxel
Day
Between Days
18 & 21
What you do
 Pre-chemotherapy medications by IV or mouth to prevent allergic reactions
 IV paclitaxel and carboplatin therapy
 Physical examination that may include a pelvic exam
 Routine blood tests
 Complete quality of life questionnaires
Day 22

Days 1
Return to your doctor’s office for your next exam and to begin the next cycle.
Study Plan
Another way to find out what will happen to you during the study is to read the chart below. Start
reading at the top and read down the list, following the lines and arrows.
Start Here
Patients with certain types of cervical cancer
who have given informed consent
Eligible patients
Randomize (You will be in one Group or the other)
(You will be in one Group or the other)
Arm A - Control Arm
Arm B - Intervention Arm
Standard radiotherapy plus
chemotherapy
Standard radiotherapy plus
chemotherapy, followed by
additional chemotherapy
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Informed Consent
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HOW LONG WILL I BE IN THE STUDY?
You will be asked to receive cisplatin and radiation therapy for 8 weeks and if randomized to Arm B
you will receive an additional 12 weeks of chemotherapy with carboplatin and paclitaxel.
After you are finished treatment on the study, the study doctor will ask you to visit the office for
follow-up exams every three months for the first two years and then every six months for the next
three years after completion of your study treatment. If for any reason you are not able to complete
study treatment we will still ask you to visit your doctor’s office for follow up exams and we will
continue to collect data on your health status from your medical records during this period. In the
event that you withdraw from the study entirely, no further information will be collected about you
from the date we notify the study center of your withdrawal onward. We will still maintain any data
collected about your health status prior to the date you choose to withdraw from study
CAN I STOP BEING IN THE STUDY?
Yes. You can decide to stop at any time. Tell the study doctor if you are thinking about stopping or
decide to stop. He or she will tell you how to stop safely.
It is important to tell the study doctor if you are thinking about stopping so any side effects/risks from
the study treatment can be evaluated by your doctor. Another reason to tell your doctor that you are
thinking about stopping is to discuss what follow-up care and testing could be most helpful for you.
The study doctor may stop you from taking part in this study at any time if he/she thinks it is best for
you; if you do not follow the study rules; if you become pregnant; or if the study is stopped.
WHAT SIDE EFFECTS OR RISKS CAN I EXPECT FROM BEING IN THE STUDY?
You may have side effects while on the study. Everyone taking part in the study will be watched
carefully for any side effects. However, doctors don’t know all the side effects that may happen. In
addition, there may be risks associated with this study that are presently unknown or unforeseeable.
The researchers don’t know whether giving the additional chemotherapy treatment in this study might
increase the chance of you getting short or longer-term side effects. Side effects may be mild or very
serious. Your health care team may give you medicines to help lessen side effects. Many side effects
go away soon after you stop taking the chemotherapy drugs and receiving radiation. In some cases,
side effects can be serious because they can be long lasting, may never go away, may result in
hospitalization, or may be life-threatening. There also is a risk of death.
You should talk to your study doctor about any side effects that you have while taking part in the
study.
Risks and side effects related to the cisplatin:
Likely
 Fatigue
 Low white blood cell counts - this may make you more susceptible to infection
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Informed Consent
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
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Low red blood cell counts which may cause tiredness, shortness of breath or fatigue
Decrease in kidney function
Loss of appetite and weight loss
Diarrhea, constipation, nausea and vomiting, and abdominal pain
Numbness and pain of the hands and feet
Skin rash
Changes in taste
Ringing in the ears and hearing loss
Changes in electrolytes in the blood such as magnesium and potassium
Less Likely
 Allergic reactions
 Chills and fever with aches and pains
 Low platelet count - this may make you bruise more easily and bleed longer if injured
 Sores in mouth and throat (that can lead to difficulty swallowing and dehydration)
 Altered vision
 Skin irritation and swelling if the drug that is being put into the vein leaks into the surrounding
skin
 Complete hair loss
Rare but serious
 Seizures
 Secondary cancers such as acute leukemia
 Kidney failure requiring dialysis
 Deafness
Risks and side effects related to radiation therapy include those which are listed below. The side
effects can be serious and may require you to be hospitalized or may be irreversible, long-term, lifethreatening, or fatal.
Likely:
 Tanning or reddening of the skin which is exposed to the radiation beam
 Burning or pain during urination or defecation
 Diarrhea
 Permanent pubic hair loss
Less likely but serious:
 Damage to the small or large intestine or rectum or ureter or bladder which may require
medications, hospitalization for management, or rarely a surgical procedure to repair
Rare:
 Nerve damage which may cause numbness or weakness in the legs
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Risks and side effects related to the carboplatin:
Likely:
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Low white blood cell counts (this may make you more open to infection)
Low platelet count (this may make you bruise more easily and bleed longer if injured)
Low red blood cell count which may cause tiredness or shortness of breath
Tiredness
Loss of appetite and weight loss
Diarrhea, constipation, nausea and vomiting and abdominal pain
Complete hair loss
Skin rash
Changes in taste
Changes in minerals in the blood such as magnesium and potassium
Less Likely:
 Numbness or tingling in the fingers and toes
 Ringing in the ears and hearing loss
 Allergic reactions
 Chills and fever with aches and pains
 Decrease in kidney or liver function
 Sores in mouth and throat (that can lead to difficulty swallowing and dehydration)
 Changes in vision
Rare but serious:
 Seizures
 Other cancers such as acute leukemia
 Kidney failure requiring dialysis
 Deafness
 Death
Risks and side effects related to the paclitaxel:
Likely:
 Low white blood cell count (this may make you more open to infection)
 Low platelet count (this may make you bruise more easily and bleed longer if injured)
 Low red blood cell count which may cause tiredness or shortness of breath
 Mild to severe allergic reaction which may be life-threatening with hives, wheezing, and low
blood pressure
 Numbness and pain of the hands and feet that sometimes worsens with additional treatment and
may not disappear after the drug is stopped. This may lead to difficulty walking, buttoning
clothes, etc;
 Hair loss
 Muscle weakness and muscle loss
 Muscle and joint aches
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Less Likely:
 A slowing of the heart rate (a slow pulse is not harmful, however if you should develop any
other irregularities in heart rate during treatment, an EKG and other tests may be required)
 Irregular heartbeats
 Heart attack
 Nausea and/or vomiting
 Diarrhea
 Sores in the mouth or throat (that can lead to difficulty swallowing and dehydration)
 Tiredness
 Lightheadedness
 Headaches
 Kidney damage
 An increase in triglyceride level (a blood lipid) levels which increases risk of hardening of the
arteries
 Liver damage
 Confusion or mood change
 Skin tissue damage if some of the drug leaks from the vein while it is being given
 Changes in taste
 Irritation and swelling of the skin in an area previously treated with radiation therapy
 Rash
 Inflammation of the colon, pancreas or lungs
 Blurred vision or other changes in eyesight such as sensation of flashing lights or spots
Rare but serious:
 Liver failure
 Swelling of the brain
 Seizures
 Death
Reproductive risks: You should not become pregnant while on this study because the drug(s) in this
study can affect an unborn baby. Women should not breastfeed a baby while on this study. It is
important you understand that if you could become pregnant, you need to use birth control while
on this study. Check with your study doctor about what kind of birth control methods to use and how
long to use them. Some methods might not be approved for use in this study. If you are capable of
becoming pregnant, a pregnancy test will be required before starting the study. You should notify your
health care team immediately if you think you have become pregnant while participating in this study.
Pregnancy occurring up to 6 months after completion of the study must also be reported to the
healthcare team. Your treatment may cause temporary or permanent sterility. Please discuss this with
your doctor if you have any concerns about future fertility.
You should notify your healthcare team immediately if you think you have become pregnant while
participating in this study. Pregnancy occurring up to 6 months after completion of the study must also
be reported to the study doctor” as mentioned in section 9.2.4 of the protocol
For more information about risks and side effects, ask your study doctor.
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ARE THERE BENEFITS TO TAKING PART IN THE STUDY?
Taking part in this study may or may not make your health better. While doctors hope adding
additional chemotherapy cycles with carboplatin and paclitaxel to the usual treatment will be more
useful against cancer compared to the usual treatment alone, there is no proof of this yet. We do know
that the information from this study will help doctors learn more about carboplatin and paclitaxel as a
treatment for your type of cancer. This information could help future cancer patients.
WHAT OTHER CHOICES DO I HAVE IF I DO NOT TAKE PART IN THIS STUDY?
Your other choices may include:
 Getting treatment or care for your cancer without being in a study
 Taking part in another study
 Getting no treatment
Talk to your doctor about your choices before you decide if you will take part in this study.
WHAT ABOUT CONFIDENTIALITY?
Efforts will be made to keep your personal information confidential, and GOG and RTOG procedures
may include removing your name and other identifying information from data collected during the
Study, in order to protect your privacy. However, we cannot guarantee total confidentiality. Portions of
your medical records will be sent to the Australia New Zealand Gynecologic Oncology Group
(ANZGOG), GOG Administrative Office, the GOG Statistical and Data Center, RTOG Headquarters
and possibly to the GOG Tissue Bank, and the RTOG Biospecimen Resource, to be reviewed and
analyzed by physicians and other Study personnel. Your records may be accessed by GOG
representatives, by the Cancer Trials Support Unit (CTSU), the Food and Drug
Administration (FDA), and by the NCI for research, quality assurance, and data analysis purposes.
In addition, your records may be reviewed by the Food and Drug Administration (FDA), or other
agencies of the Department of Health and Human Services (DHHS) for research or regulatory
purposes. Also, information from the Study may be given to government agencies in other countries
where the study drug may be considered for approval.
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by
U.S. Law. This Web site will not include information that can identify you. At most, the Web site will
include a summary of study results. You can search this Web site at any time.
Under NCI policy, data from this Study may be provided to another researcher at some future time for
use in an approved research project. If this occurs, the researcher must agree to keep individual patient
information confidential.
When the research results are published or discussed in conferences, no information will be included
that reveals your identity.
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The National Institutes of Health (NIH) has issued GOG a Certificate of Confidentiality, which
protects GOG from being forced to disclose personal information about you in response to a subpoena
or other request in a federal or state legal proceeding.
You should understand that a Certificate of Confidentiality does not prevent you or a member of your
family from voluntarily releasing information about yourself or your involvement in this research. If an
insurer, employer, or other person obtains your written consent to receive research information, then
the researchers may not use the Certificate to withhold that information.
[Note to Local Investigators: The Department of Health and Human Services (DHHS) has
recommended that HIPAA Privacy Rule requirements be addressed by the local institution. This may
be done either in a stand-alone authorization or as part of the informed consent document, depending
on institutional policy.]
WHAT ARE THE COSTS OF TAKING PART IN THIS STUDY?
You and/or your health plan/ insurance company will need to pay for all of the costs of treating your
cancer in this study, including the cost of managing the side effects of therapy. Some health plans will
not pay these costs for people taking part in studies. Check with your health plan or insurance
company to find out what they will pay for. You will be responsible for paying any deductibles,
coinsurance, and co-payments as required under the terms of your insurance plan(s).
You will not be paid for taking part in this study. The institution receives payment that covers some
but not all of the costs of the study.
For more information on clinical trials and insurance coverage, you can visit the National Cancer
Institute’s Web site at http://cancer.gov/clinicaltrials/understanding/insurance-coverage. You can
print a copy of the “Clinical Trials and Insurance Coverage” information from this Web site.
Another way to get the information is to call 1-800-4-CANCER (1-800-422-6237) and ask them to
send you a free copy.
WHAT HAPPENS IF I AM INJURED BECAUSE I TOOK PART IN THIS STUDY?
It is important that you tell your study doctor, __________________ [investigator’s name(s)], if you
feel that you have been injured because of taking part in this study. You can tell the doctor in person
or call him/her at __________________ [telephone number].
You will get medical treatment if you are injured as a result of taking part in this study. You and/or
your health plan will be charged for this treatment. The study will not pay for medical treatment.
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WHAT ARE MY RIGHTS IF I TAKE PART IN THIS STUDY?
Taking part in this study is your choice. You may choose either to take part or not to take part in the
study. If you decide to take part in this study, you may leave the study at any time. No matter what
decision you make, there will be no penalty to you and you will not lose any of your regular benefits.
Leaving the study will not affect your medical care. You can still get your medical care from our
institution.
We will tell you about new information or changes in the study that may affect your health or your
willingness to continue in the study.
In the case of injury resulting from this study, you do not lose any of your legal rights to seek payment
by signing this form.
WHO CAN ANSWER MY QUESTIONS ABOUT THE STUDY?
You can talk to your study doctor about any questions or concerns you have about this study. Contact
your study doctor __________________ [name(s)] at __________________ [telephone number].
For questions about your rights while taking part in this study, call the ________________________
[name of center] Institutional Review Board (a group of people who review the research to protect
your rights) at __________________ (telephone number). [Note to Local Investigator: Contact
information for patient representatives or other individuals in a local institution who are not on the IRB
or research team but take calls regarding clinical trial questions can be listed here.]
Where can I get more information?
You may call the National Cancer Institute's Cancer Information Service at:
1-800-4-CANCER (1-800-422-6237)
You may also visit the NCI Web site at http://cancer.gov/

For NCI’s clinical trials information, go to: http://cancer.gov/clinicaltrials/

For NCI’s general information about cancer, go to http://cancer.gov/cancerinfo/
You will get a copy of this form. If you want more information about this study, ask your study
doctor.
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by
U.S. Law.
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Signature
I have been given a copy of all _____ [insert total of number of pages] pages of this form. I have read
it or it has been read to me. I understand the information and have had my questions answered. I
agree to take part in this study.
_________________________________________________________________
SIGNATURE OF PATIENT
DATE
Protocol and Consent approved by:
___________________________________________
RESEARCH COMMITTEE
DATE
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GENERAL INFORMATION ABOUT THE COLLECTION AND USE OF SPECIMENS FOR
RESEARCH
You are being asked to allow samples from your tumor (if available from a previous surgery or biopsy)
and blood to be submitted and used in research. Such bodily materials are referred to as specimens and
are very important in helping doctors and scientists learn more about caring for and treating people
with cancer and other diseases. The use of specimens in scientific research can also help doctors and
scientists understand why some people develop cancer and others don’t, why some people have or
don’t have side effects to cancer therapies, and why some people have cancers that respond or don’t
respond well to current therapies, for example.
The research that may be done with your specimens is not designed specifically to help you, but it may
help others with cancer or other diseases in the future. Reports about research done with your
specimens will not be given to you or your doctor, or be put in your health record. The research will
not have an effect on your care.
When research is performed on specimens connected with clinical information about the person,
including the person’s disease and how the person responds to treatment, doctors and scientists can
specifically study how to prevent, detect, treat and cure cancer and other diseases, or how to predict
response to therapy, toxicities, recurrence and overall survival.
The GOG and RTOG uses procedures designed to protect your privacy and confidentiality. The chance
that information from your health records will be incorrectly released is very small, but you should be
aware of this risk. To protect your privacy and confidentiality, the research investigators that study
your specimens will never be given your name, address, phone number, Social Security number or any
other personal information. In addition, your specimens will never be labeled with your name or other
type of personal identifier. Your specimens will be labeled with a unique series of letters and numbers.
The GOG and RTOG uses the unique series of letters and numbers as confidential codes to keep track
of the specimens, and sends research investigators specimens labeled only with these codes.
Your specimens will be used for research purposes and will not be sold. However, the research done
with your specimens may help to develop new products and therapies in the future, or may be used to
establish a cell line or test that could be patented and licensed. In any event, there are no plans to
provide you with any direct financial compensation.
If you agree now that your tumor (if available from a previous surgery or biopsy) and blood can be
submitted and used for this research study and/or for future research, your specimens will be used for
research purposes until they are used up or until you change your mind. At that time, please contact
the staff at your treating institution, typically your doctor or nurse, and tell them that you have changed
your mind about allowing your specimens to be used for research. The staff at your treating institution
will notify the GOG or RTOG regarding your wishes about using your coded specimens and clinical
information for research. If necessary, the GOG or RTOG will destroy (incinerate) all of your
specimens to make sure that they will no longer be used for research.
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SPECIFIC INFORMATION FOR THIS RESEARCH STUDY
You are being asked to allow samples of your tumor, if left over from a previous surgery or biopsy, to
be submitted and used in research. You are also being asked to allow your blood specimens to be
collected for submission and use for this research study.
The choice to let us collect your specimens and use them for this research study is up to you. No
matter what you decide to do, it will not affect your care. You can still participate in this research
study if you do not give permission to allow your specimens to be used for this research study.
What Will Happen To Your Tumor and Blood If You Agree
If you give permission for your tumor to be submitted and used for this research study, your health
care team will send your tumor to the GOG Tissue Bank in Columbus, Ohio or to the RTOG
Biospecimen Resource in San Francisco, CA.
If you give permission for your blood to be submitted and used for this research study, your health care
team will draw at total of about 8 teaspoons (40mL) of blood from you. About two teaspoons (10mL)
of whole blood will be collected before starting study treatment. About two teaspoons of blood
(10mL) will be collected to prepare plasma three times, once before each of the first three chemo
treatments. Your plasma, and whole blood specimens will be shipped to the GOG Tissue Bank in
Columbus, Ohio or to the RTOG Biospecimen Resource in San Francisco, CA. Both the GOG Tissue
Bank and the RTOG Biospecimen Resource are approved by the National Cancer Institute (NCI) to
store (bank), process and distribute specimens from patients who agree to participate in the studies
conducted by the GOG and RTOG.
The GOG Tissue Bank and the RTOG Biospecimen Resource will be responsible for isolating DNA
from the two teaspoons of blood, and for shipping specimens (tumor, plasma and DNA) submitted for
this research study to approved laboratories for testing. Laboratory testing will be carried out in
specimens from women who give permission to participate in this research study, and will look for
changes in proteins and DNA for example that may be associated with treatment response or failure,
side effects, disease progression or survival. This type of testing might lead to discoveries about why
some cervical cancer patients live longer, respond well to anti-cancer therapies, have side effects to
treatment or live longer while others do not.
After the laboratory testing is finished, the results will be sent to the GOG Statistical and Data Center
in Buffalo, New York for analysis. The results from the laboratory testing will be studied to determine
if any of the laboratory testing may be used to identify which patients in the future might be more or
less likely to respond to the study drug, have a good prognosis or have side effects. Reports of this
research done on your specimens will not be given to you or your doctor, or be put in your health
record.
MAKING YOUR CHOICES FOR THIS RESEARCH STUDY
Please read each sentence below and think about your choice. After reading each sentence, circle
"Yes" or "No". No matter what you decide to do, it will not affect your care. You will still be
allowed to participate in this research study even if you don’t want your specimens to be
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submitted and used for this research study. If you have any questions, please talk to your
doctor, nurse or other type of healthcare provider.
1. Do you give permission for some of your tumor, if available from a previous surgery or biopsy,
to be submitted and used for this research study?
Yes
No
2. Do you give permission for some of your blood to be collected for submission and use for this
research study?
Yes
No
Please sign your name after you circle your answers.
 I do not wish to participate in the optional research portion of this study.
Your signature:
Signature of Doctor/Nurse:
Date:
Date:
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SPECIFIC INFORMATION FOR FUTURE RESEARCH
The last section of the consent will ask you to decide whether your specimens, if still available after
completion of this research study, can be stored indefinitely and used for future cancer research or for
research for health problems other than cancer. We will also ask your permission to use the clinical
information that the GOG or the RTOG will collect about you as part of your participation in this
research study to be utilized for future research that will use your specimens. Next, we will ask for
permission to contact you in the future to participate in more research.
If you agree to allow your specimens to be used for future research, there is a chance that your
specimens may be used to study changes in genetic material that are passed on in families or that are
not passed on in families but are either natural changes or influenced by environment and lifestyle.
These tests can focus on a section of genetic material (DNA), genetic material packaged into
chromosomes or examine all of the genetic material called the whole genome. The results can then be
studied to identify changes in genetic material that influence the development of diseases including
cancer or the effectiveness of specific treatments. Reports of this research done in your specimens will
not be given to you or your doctor, or be put in your health record.
Please read the information sheet called "How Is Tissue Used for Research" to learn more about tissue
research. This information sheet is available to all at the following website:
http://www.cancerdiagnosis.nci.nih.gov/specimens/patient.pdf
The choice to let us collect your specimens for future research is up to you. No matter what you
decide to do, it will not affect your care. You can still participate in this GOG and RTOG study if
you do not allow your specimens to be used for future research.
Making Your Choices About Future Research
Please read each sentence below and think about your choice. After reading each sentence, circle "Yes"
or "No". No matter what you decide to do, it will not affect your care. If you have any questions,
please talk to your doctor, nurse or other type of healthcare provider.
1. Do you give permission for your specimens, if still available after this research study is
completed, to be used in future research to learn about, prevent, or treat cancer?
Yes
2.
Do you give permission for your specimens, if still available after this research study is
completed, to be used in future research to learn about, prevent or treat health problems
other than cancer (for example: diabetes, Alzheimer's disease, or heart disease)?
Yes
3.
No
No
Do you give permission for the clinical information collected by the GOG as part of your
participation in this study to be used for future research that uses your specimens?
Yes
No
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4.
Do you give permission for your specimens, if still available after this research study is
completed, to be used for future research to study changes in genetic material?
Yes
5.
No
Do you give permission for someone from your GOG institution such as your doctor or
nurse to contact you in the future to ask you to take part in more research?
Yes
No
Please sign your name after you circle your answers.
 I do not wish to participate in the optional research portion of this study.
Your signature:
Date:
Signature of Doctor/Nurse:
Date:
GOG-0274/RTOG 1174/ANZGOG-0902 Patient Information and Consent Form version 1.0, 01 December 2011